GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2023. IT IS UNKNOWN HOW LONG THE FILTER HAD BEEN IN THE PATIENT. THE PATIENT DID NOT HAVE ANY ANATOMICAL CONDITIONS OR ABNORMALITIES THAT WOULD HAVE HAD AN IMPACT ON FILTER RETRIEVAL. IT IS UNKNOWN IF AND WHEN THE FILTER WILL BE RETRIEVED.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTED INFORMATION: D9, H3, H6 (ANNEXES A, G) SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING ATTEMPTED RETRIEVAL OF AN UNSPECIFIED CELECT PLATINUM FILTER, THE LOOP OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE BROKE. THE LOOP DID NOT DETACH FROM THE DEVICE. THE FILTER, WHICH WAS INITIALLY PLACED BY ANOTHER PHYSICIAN, WAS UNABLE TO BE RETRIEVED AFTER TRYING FOR THIRTY MINUTES; THEREFORE, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. WHEN THE SNARE WAS REMOVED, THE USER NOTED THAT THE LOOP WAS BROKEN. REPORTEDLY, THE PHYSICIAN WAS PLANNING TO ATTEMPT FILTER RETRIEVAL AGAIN THE WEEK AFTER THE REPORTED EVENT. IMAGES PROVIDED BY THE CUSTOMER, TAKEN PRIOR TO THE RETRIEVAL ATTEMPT, SHOW ONE LEG OF THE FILTER POINTING UPWARD. NO PORTION OF THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET REMAINED INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. WILLIAM COOK EUROPE HAS BEEN NOTIFIED OF THE FILTER COMPLAINT (MANUFACTURER REPORT # 3002808486-2023-00214). ADDITIONAL INFORMATION WAS RECEIVED 07AUG2023. IT IS UNKNOWN HOW LONG THE FILTER HAD BEEN IN THE PATIENT. THE PATIENT DID NOT HAVE ANY ANATOMICAL CONDITIONS OR ABNORMALITIES THAT WOULD HAVE HAD AN IMPACT ON FILTER RETRIEVAL. IT IS UNKNOWN IF AND WHEN THE FILTER WILL BE RETRIEVED. INVESTIGATION EVALUATION: REVIEWS OF THE MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED FOR THE LOT. A REVIEW OF NON-CONFORMANCES RELATED TO ¿RETRIEVAL LOOP IS DAMAGED WHILE RETRIEVING FILTER¿, COVERING A PERIOD FROM 01JAN2020 TO 18SEP2023, REVEALED NO COMPLAINT-RELATED NON-CONFORMANCES. THE PRODUCT IFU PROVIDES STEP-BY-STEP INSTRUCTIONS FOR HOW TO PLACE THE SHEATH, ADVANCE THE LOOP, AND SURROUND/CATCH THE FILTER HOOK WITH THE LOOP BEFORE COLLAPSING THE FILTER FOR RETRIEVAL. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. IMAGES PROVIDED BY THE CUSTOMER DO NOT SHOW THE LOOP SNARE FLUOROSCOPICALLY IN ANY CAPACITY WHICH CAN BE EVALUATED. IN ADDITION, THERE WAS NO DISCUSSION OF WHETHER THE PHYSICIAN WAS ABLE TO ENGAGE THE HOOK OF THE IVC FILTER BUT COULD NOT RETRIEVE THE FILTER ITSELF. THE LOOP SNARE HAS A RATED FORCE THAT CAN BE APPLIED BEFORE IT DOES BREAK, BUT IT IS UNCERTAIN WHETHER THIS FORCE WAS APPLIED TO THE LOOP SNARE IN ATTEMPTS TO CAPTURE AND/OR COLLAPSE OF THE IVC FILTER. IN ADDITION, IF THE LOOP SNARE GETS ENTANGLED, SPINNING THE LOOP SNARE MULTIPLE TIMES WILL DETACH THE SNARE FROM THE SHAFT OF THE DEVICE. FROM THE IMAGES SUBMITTED AND THE COMPLAINT REPORT, IT CANNOT BE DETERMINED IF THE LOOP CAME BROKEN, WAS BROKEN DURING WHAT WOULD BE CONSIDERED NORMAL USE, OR IF ABNORMAL USE/STRESS BROKE THE SNARE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Description of Event or Problem

AS REPORTED, DURING A PROCEDURE INVOLVING ATTEMPTED RETRIEVAL OF AN UNSPECIFIED CELECT PLATINUM FILTER, THE LOOP OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE BROKE. THE LOOP DID NOT DETACH FROM THE DEVICE. THE FILTER, WHICH WAS INITIALLY PLACED BY ANOTHER PHYSICIAN, WAS UNABLE TO BE RETRIEVED AFTER TRYING FOR THIRTY MINUTES; THEREFORE, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. WHEN THE SNARE WAS REMOVED, THE USER NOTED THAT THE LOOP WAS BROKEN. REPORTEDLY, THE PHYSICIAN WAS PLANNING TO ATTEMPT FILTER RETRIEVAL AGAIN THE WEEK AFTER THE REPORTED EVENT. IMAGES PROVIDED BY THE CUSTOMER, TAKEN PRIOR TO THE RETRIEVAL ATTEMPT, SHOW ONE LEG OF THE FILTER POINTING UPWARD. NO PORTION OF THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET REMAINED INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. WILLIAM COOK EUROPE HAS BEEN NOTIFIED OF THE FILTER COMPLAINT.

Additional Manufacturer Narrative

E3: OCCUPATION = LEAD TECH. G4: PMA/510(K) NUMBER = K181757. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.